The global market for chronic obstructive pulmonary disease (COPD) drugs, currently worth $3 billion annually, is expected to more than triple by 2010. Even this could be an under-estimate according to data presented at this week’s meeting of the American Thoracic Society (ATS) conference in San Diego, California.
Over the next two decades, medical costs related to COPD will total $833 billion in the USA alone, according to a study by Dr Todd Lee, Northwestern University, Chicago. Soaring costs are predicted despite declining tobacco use, because more cases of COPD will be diagnosed in current or recent smokers. In another study reported at ATS, primary care physicians in five EU countries were surveyed (‘Time to Live’ Report). Over two thirds of the physicians polled believe that COPD will be the leading cause of death by 2020.
The major products jockeying for share of the COPD market are Spiriva (tiotropium bromide) marketed by Boehringer Ingelheim/Pfizer; Seretide (fluticasone/salmeterol) marketed by GSK and AstraZeneca’s Symbicort (formoterol/budesonide). The latter two products - already on the market in Europe - are currently neck and neck in a contest to gain marketing approval for COPD in the lucrative US market - so new data that might support approval is closely watched.
Professor Peter Calverley, University Hospital, Aintree, Liverpool, presented new findings from GSK’s TORCH study of Seretide (sold as Advair in the USA) versus placebo. These included a 25% reduction in moderate/severe exacerbations (p<0.001); a 3.1 point improvement in the St. George's Respiratory Questionnaire (SGRQ)(p<0.001); and a 92mL improvement in FEV1 averaged over three years (p<0.001). In a safety sub-study (n=658) there were no differences in bone mineral density or the number of patients developing cataracts between groups.
A surprising finding was an increase in pneumonia in the fluticasone-containing arms of the study (but no increase in pneumonia mortality). These results add to the primary endpoint data released in March, showing that Seretide reduced all-cause mortality by 17% in COPD patients over a three year period (p=0.052).
Astra Zeneca’s Symbicort featured in a presentation which showed that the drug improved airway inflammation and COPD symptoms. Dr Derk Bathoorn and colleagues, Department of Pulmonary Diseases, University Medical Centre, Groningen, The Netherlands, studied the effects of Symbicort or oral prednisolone versus placebo on induced sputum eosinophils and lung function during exacerbations in mild to moderate COPD.
Significant reductions in eosinophil counts were observed with the combination (p=0.01) and prednisolone (p=0.01) versus placebo. Both treatments also resulted in significantly reduced total symptoms versus placebo. An improvement in FEV1 of 125 ml was observed with Symbicort and 27ml with prednisone.
The authors believe that the improvements in inflammation and symptoms observed suggest that mild to moderate COPD exacerbations could be treated with high doses of this inhaled corticosteroid/long acting beta agonist combination. COPD management increasingly is seen to focus on the prevention of exacerbations: in the ‘Time to Live’ survey, some 90% of the physicians polled said that preventing exacerbations was a prominent consideration when choosing COPD treatment.